The present invention relates to a device for prevention of involuntary urination in a female, comprising a body designed for arrangement in the vagina and made of an elastic material for compressive action on and support of the neck of the bladder.
Stress incontinence is a nuisance experienced by up to one third of all women at one time or another during their lives.
Stress incontinence is often caused by a weakening or lack of control of the musculature of the pelvic floor, which results in the lack of support of the bladder neck and closure of the urethra.
Severe cases of stress incontinence are normally relieved by surgical intervention, while minor cases of stress incontinence can often be fully or partially relieved by training or retraining of the pelvic musculature.
Training or retraining of a pelvic muscle may, however, extend over many months and, as mentioned, may not in all cases relieve the problem completely.
It is therefore of great importance to find a product which can relieve stress incontinence.
The use of sanitary towels and napkins for relieving the inconveniences connected with involuntary urination is generally known. This, however, is a method associated with great disadvantages for the woman, as the sanitary towels are unhandy and voluminous, among other things.
Besides, it is known that stress incontinence may be relieved by the use of a tampon-like device which is arranged in the vagina for compressive action and support of the neck of the bladder.
Such a device for relief of stress incontinence is known from, for example, U.S. Pat. No. 4,019,498. This device consists of a body of compressible elastic material which is compressed and then placed in a bag. The bag with the body is inserted in the vagina, whereupon the bag is punctured. The body will then press against the neck of the bladder and in reality block the urethra. This method partly involves a cost-increasing component--the bag--and partly there is a risk of damaging the vagina and adjacent tissue when puncturing the bag.
Furthermore, it is impossible or difficult to adjust the position of the body after mounting in the vagina. Additionally, the body acts purely by the compressibility of the material, for which reason it is necessary to manufacture it in several different sizes.
EP-A-363421 also describes a device for arrangement in a woman's vagina with the object of relieving incontinence. This device also has the disadvantage that it acts as a support to the bladder neck merely in consequence of the compression taking place depending on the size of the vagina and the size of the body.
It is therefore also in this case necessary to manufacture different sizes to compensate for the different vaginal diameters.
Finally, EP-A-264258 describes an incontinence device--specifically for use in vaginal and rectal prolapse--designed as a U-shaped elastic body, which acts by lifting the neck of the bladder, wherein, after being arranged relatively far into the vagina close to the cervix, the body returns to its original position, and one leg of the U which is designed with a forked structure, bears against the bladder/neck of the bladder which is lifted, whereby continence is obtained.
This is thus a relatively rigid structure, which is also designed in rather large dimensions.
This device, as well, is required to be manufactured in different sizes to compensate for the different vaginal diameters, as its lift is exclusively due to its shape, just as it is uncomfortable to wear owing to its rigid and fairly large structure.
A common feature of the above incontinence products is thus that it is necessary to manufacture the product in many different sizes to compensate for the various vaginal diameters.
This is partly economically inappropriate, and partly the body will not have an optimum function even after careful selection of size according to a woman's vaginal diameter, as the support by the bodies of the bladder neck will vary according to the physical posture of the woman and the state of tension of her pelvic muscle. There is thus a great risk that by use of the above-mentioned devices, the woman will still suffer from involuntary urination, and/or that the device will inconvenience, cause pain or even damage the vaginal mucuos membrane, when the woman is in physical movement or tightens her pelvic musculature.
Thus, the known devices are economically unsuitable, just as they do not have an optimum function throughout their service life.